Active Communities - Adherence to Physical Activity

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Active Communities - Adherence to Physical Activity Among Persons With Type 2 Diabetes, Cardiovascular Disease and/or Obesity - With a Focus on IT as a Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493345
• Other study ID #: 21076311
• Status: Recruiting
• Start date: August 5, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2022
• Source: Rigshospitalet, Denmark
• Contact: Mathias Ried-Larsen, PhD
• Phone: 0045 35 45 06 99
• Email: mathias.ried-larsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of this study is to investigate whether a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities (e.g. local sports and exercise associations) can support persons with type 2 diabetes, cardiovascular disease and/or obesity in maintain physical activity levels.

Description:

This study is an evaluation of a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities. Persons with type 2 diabetes, cardiovascular disease and/or obesity initiating a lifestyle program (8-12 weeks duration) in the municipality of Odsherred, Denmark, will be included in the study. We will include sixty (n=60) persons or the number of persons recruited at the end of the recruitment period, December 1, 2022 - whichever is reached first. Participants will undergo objective measurement of physical activity level, test of standing balance, 6-minute walk test, measurement of body composition, and answer questionnaires related to their background (education, job situation, civil status), health, lifestyle and well-being. Measurements will be performed before and after participants undergo a lifestyle program, and 3 and 6 months after termination of the lifestyle program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Citizens in the municipality of Odsherred undergoing a municipality-based lifestyle program

• Obese, or diagnosed with type 2 diabetes or cardiovascular disease

Exclusion Criteria:

• reliant on a wheelchair

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Obese

Intervention

Behavioral:
• Bridge-building between municipality-based lifestyle programs and community-based physical activities
Four co-created bridge-building activities has been implemented in the municipality of Odsherred, including (1) A digital portal for information and sharing of knowledge, (2) Visits between municipal rehabilitation programs and community-based physical activities, (3) Co-created teams for the target group, and (4) a 'Bridge builder' coordinator.

Locations

Country	Name	City	State
Denmark	Centre for Physical Activity Research, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Center for Clinical Research and Prevention, Steno Diabetes Center Sjaelland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and fidelity	Feasibility and fidelity are evaluated using research progression criteria. Every domain is scored as either 1) Progress to RCT (randomized controlled trial) (green), 2) Amend before progressing to RCT (amber) or 3 do not progress to RCT (red).; Domains include: Satisfaction with project activities; Recruitment rate; Test- and participation burden; Retainment; Referral rate; Adherence; Physical activity improvement	From baseline (0 months) to follow-up (9 months)
Secondary	Moderate and vigorous physical activity (MVPA) time	Change in time spend in MVPA (Accelerometer AX3)	From baseline (0 months) to follow-up (9 months)
Secondary	Sitting time	Change in time spend sitting (Accelerometer AX3)	From baseline (0 months) to follow-up (9 months)
Secondary	Low-intensity physical activity (LPA) time	Change in time spend in LPA (Accelerometer AX3)	From baseline (0 months) to follow-up (9 months)
Secondary	Total physical activity (TPA) level	Change in TPA measured in counts per minute (CPM) (Accelerometer AX3)	From baseline (0 months) to follow-up (9 months)
Secondary	Steps	Change in number of steps (Acceleromter AX3)	From baseline (0 months) to follow-up (9 months)
Secondary	Six-minute walk distance	Change in distance walked in a period of 6 minutes (6-minute walk test)	From baseline (0 months) to follow-up (9 months)
Secondary	Standing balance	Change in time spend in three standing positions (0-30 sec)	From baseline (0 months) to follow-up (9 months)
Secondary	Body weight	Change in body weight (bioimpedance scale)	From baseline (0 months) to follow-up (9 months)
Secondary	Fat mass	Change in fat mass (bioimpedance scale)	From baseline (0 months) to follow-up (9 months)
Secondary	Fat percentage	Change in fat percentage (bioimpedance scale)	From baseline (0 months) to follow-up (9 months)
Secondary	Fat free mass	Change in fat free mass (bioimpedance scale)	From baseline (0 months) to follow-up (9 months)
Secondary	Muscle mass	Change in muscle mass (bioimpedance scale)	From baseline (0 months) to follow-up (9 months)
Secondary	Body mass index	Change in body mass index (BMI)	From baseline (0 months) to follow-up (9 months)
Secondary	Mental well-being	Change in 5-item World Health Organization well-being index (WHO-5)	From baseline (0 months) to follow-up (9 months)
Secondary	Risk of depression	Change in number of participants scoring <50 in the WHO-5	From baseline (0 months) to follow-up (9 months)
Secondary	Physical health-related quality of life	Change in the SF-12 physical component summary (PCS)	From baseline (0 months) to follow-up (9 months)
Secondary	Mental health-related quality of life	Change in the SF-12 mental component summary (MCS)	From baseline (0 months) to follow-up (9 months)
Secondary	Perceived stress	Change in perceived stress scale (PSS) score	From baseline (0 months) to follow-up (9 months)
Secondary	Loneliness	Change in Three-Item Loneliness Scale (T-ILS) score	From baseline (0 months) to follow-up (9 months)